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Network-Based Support to Help Community Coalition Members Choose and Use Strategies to Improve Child Health

31 sierpnia 2026 zaktualizowane przez: Travis R Moore, University of Pittsburgh

Pilot Trial of Network-Based Implementation Strategies to Increase Coalition Adoption and Early Implementation of Evidence-Informed Strategies for Child Health

Community coalitions bring together residents and organizations to improve child health, but they may need support to identify and put research-supported strategies into practice. This study will examine whether a program called FICAS can be delivered successfully and is useful to coalition members. FICAS uses information about relationships within a coalition to help involve people with relevant perspectives, share evidence, compare possible strategies, make decisions, and adjust support as the coalition's work develops.

Three community coalitions will participate. All three will eventually receive Catalyzing Communities, a program that provides facilitated meetings, collaborative planning, technical assistance, and funding for coalition-led action. One coalition will begin the program later, one will receive Catalyzing Communities alone, and one will receive Catalyzing Communities with FICAS. The study will help determine whether FICAS and the study procedures should be refined and tested in a larger study.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

3300

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Travis R Moore, PhD
  • Numer telefonu: 512-914-4880
  • E-mail: trm250@pitt.edu

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15216
        • University of Pittsburgh
        • Kontakt:
        • Główny śledczy:
          • Travis R Moore, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria

Coalition-level criteria

  • Coalition focuses on child health, childhood obesity prevention, healthy eating, active living, nutrition security, policy, systems, or environmental change, or related community health priorities.
  • Coalition works in or serves a community experiencing socioeconomic disadvantage.
  • Coalition has multisector participation.
  • Coalition has identifiable leadership or backbone capacity to participate in the study.
  • Coalition is willing to participate in study procedures and data collection and accept randomized coalition-level assignment.
  • Coalition has a feasible membership roster or is able to work with the study team to construct one and has an identifiable leadership contact.
  • Coalition can support participant recruitment and scheduling without coercing individual participation.

Individual-level criteria

  • Age 18 years or older.
  • Coalition member, leader, staff member, partner, changemaker, committee or core-group participant, named network connection, survey-only participant, invited guest, or other adult with relevant community, organizational, policy, professional, or implementation expertise or connections.
  • Able to provide informed consent.
  • Able to participate in English.
  • For direct committee or core-group participants, able to participate through the internet, telephone, or another study-supported mode.
  • Willing to complete the study activities applicable to the participant's role, which may include meetings, surveys, network assessments, or interviews.

Exclusion Criteria

Coalition-level criteria

  • Coalition is unable to participate in required study activities.
  • Coalition lacks a feasible membership roster or the ability to construct one with study-team assistance, or lacks an identifiable leadership contact.
  • Coalition is unwilling to accept randomized coalition-level assignment.
  • Coalition is participating in a comparable formal coalition intervention that would prevent interpretation of the study findings.

Individual-level criteria

  • Younger than 18 years.
  • Unable to provide informed consent.
  • Unable to participate in English.
  • Does not have an eligible coalition, professional, community, organizational, policy, or implementation role, expertise, or connection.
  • For direct committee or core-group participants, unable to participate through an available study-supported mode.
  • Participation would create an unmanaged conflict or undue pressure that cannot be resolved.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Inny: Delayed Control
During the initial comparison period, this coalition will receive study assessments and retention contacts but no active Catalyzing Communities or FICAS intervention. After the prespecified pre-crossover assessment, the coalition will cross over to Catalyzing Communities only. It will not receive the FICAS augmentation during the registered comparison period.
Catalyzing Communities is a coalition-centered implementation-support platform that includes facilitated coalition convening, group model building, technical assistance, and seed funding. The platform supports shared systems understanding, identification of action opportunities, selection of an evidence-informed strategy, action planning, and early coalition-led implementation. Activities may be delivered virtually or in person and continue across the active intervention period.
Aktywny komparator: Positive Control: Catalyzing Communities
This coalition will receive the Catalyzing Communities base implementation-support platform, including coalition convening, group model building, technical assistance, and seed funding to support coalition-led selection and early implementation of an evidence-informed strategy. It will not receive the FICAS augmentation.
Catalyzing Communities is a coalition-centered implementation-support platform that includes facilitated coalition convening, group model building, technical assistance, and seed funding. The platform supports shared systems understanding, identification of action opportunities, selection of an evidence-informed strategy, action planning, and early coalition-led implementation. Activities may be delivered virtually or in person and continue across the active intervention period.
Eksperymentalny: Augmented Treatment: Catalyzing Communities Plus FICAS
This coalition will receive the Catalyzing Communities base implementation-support platform plus the FICAS multicomponent implementation intervention. FICAS adds data-informed committee selection, opinion leader engagement, structured evidence review, structured decision support, and online network monitoring and adaptation.
Catalyzing Communities is a coalition-centered implementation-support platform that includes facilitated coalition convening, group model building, technical assistance, and seed funding. The platform supports shared systems understanding, identification of action opportunities, selection of an evidence-informed strategy, action planning, and early coalition-led implementation. Activities may be delivered virtually or in person and continue across the active intervention period.
FICAS is a multicomponent implementation intervention delivered as an augmentation to Catalyzing Communities. It includes five strategies: using roster and network data to strengthen committee representation and connectivity; identifying and engaging influential or bridging coalition members; progressively assembling and reviewing research, practice, community, and policy evidence; using structured criteria and deliberation to select an evidence-informed strategy; and monitoring coalition network data to guide adaptations. Components are delivered at relevant milestones across evidence review, strategy selection, and early implementation.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Participation and Reach
Ramy czasowe: From the beginning of participant recruitment through the primary assessment window, up to 12 months after intervention initiation
The number of eligible coalition members who provide informed consent and complete at least one study data-collection activity will be divided by the total number of eligible coalition members invited to participate and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater study reach.
From the beginning of participant recruitment through the primary assessment window, up to 12 months after intervention initiation
Percentage of Enrolled Participants Retained Through the Primary Endpoint
Ramy czasowe: Baseline through intervention month 12
The number of participants in the baseline cohort who complete the final scheduled primary assessment will be divided by the number enrolled in the baseline cohort and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater retention.
Baseline through intervention month 12
Mean Acceptability of Intervention Measure Score for FICAS
Ramy czasowe: Intervention months 6, 9, and 12
Acceptability of FICAS will be measured using the four-item Acceptability of Intervention Measure. Each item is scored from 1, completely disagree, to 5, completely agree. Item scores will be averaged to produce a mean score ranging from 1 to 5. Higher scores indicate greater perceived acceptability. Mean scores will be reported separately at each assessment.
Intervention months 6, 9, and 12
Mean Intervention Appropriateness Measure Score for FICAS
Ramy czasowe: Intervention months 6, 9, and 12
Perceived appropriateness of FICAS will be measured using the four-item Intervention Appropriateness Measure. Each item is scored from 1, completely disagree, to 5, completely agree. Item scores will be averaged to produce a mean score ranging from 1 to 5. Higher scores indicate greater perceived appropriateness. Mean scores will be reported separately at each assessment.
Intervention months 6, 9, and 12
Mean Feasibility of Intervention Measure Score for FICAS
Ramy czasowe: Intervention months 6, 9, and 12
Perceived feasibility of FICAS will be measured using the four-item Feasibility of Intervention Measure. Each item is scored from 1, completely disagree, to 5, completely agree. Item scores will be averaged to produce a mean score ranging from 1 to 5. Higher scores indicate greater perceived feasibility. Mean scores will be reported separately at each assessment.
Intervention months 6, 9, and 12

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Selected-Strategy Adoption Milestones Completed
Ramy czasowe: Intervention months 9 and 12
Coalition progress will be assessed using eight prespecified milestones: naming and actively considering a candidate strategy, formally selecting a strategy, assigning implementation roles, drafting an implementation plan, securing resources or commitments, completing launch preparation, initiating the first implementation activity, and beginning early monitoring or refinement. Each completed milestone receives one point. The number completed will be divided by eight and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater progress from strategy consideration through adoption and early action.
Intervention months 9 and 12
Normalized Early Implementation Readiness and Action-Initiation Score
Ramy czasowe: Intervention months 9 and 12
Readiness and action initiation will be assessed using a nine-indicator study-specific rubric. Indicators address confirmation of the selected strategy, implementation leadership, assigned responsibilities, a written implementation plan, timelines and milestones, resources and supports, partner commitments, launch preparation, and initiation of the first implementation action. Each applicable indicator is scored from 0, no evidence, to 3, completed or fully documented. Scores will be summed, divided by the maximum possible score for applicable indicators, and multiplied by 100. Scores range from 0 to 100. Higher scores indicate greater implementation readiness and action initiation.
Intervention months 9 and 12
Coalition Child-Health Discussion Network Density
Ramy czasowe: Pre-intervention baseline and monthly through intervention month 12
At each assessment, participants may identify up to 20 people with whom they currently discuss child health promotion. Coalition network density will be calculated as the number of observed directed child-health discussion ties among rostered coalition members divided by the total number of possible directed ties, excluding self-ties. Scores range from 0 to 1. Higher values indicate a more densely connected coalition discussion network.
Pre-intervention baseline and monthly through intervention month 12
Percentage of Child-Health Discussion Ties Connecting Different Sectors
Ramy czasowe: Pre-intervention baseline and monthly through intervention month 12
The number of reported child-health discussion ties connecting people from different organizational or community sectors will be divided by the number of reported ties with sector information and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater cross-sector connectivity.
Pre-intervention baseline and monthly through intervention month 12
Percentage of Prespecified Strategic Representation Categories Represented
Ramy czasowe: Pre-intervention baseline and intervention months 6, 9, and 12
Before intervention delivery, the study team and coalition will identify the sectors, roles, perspectives, and community constituencies needed for the coalition or core committee. At each assessment, the number of prespecified categories represented by at least one active member will be divided by the total number of prespecified categories and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater strategic representation.
Pre-intervention baseline and intervention months 6, 9, and 12
Mean Coalition-Wave Dyadic Trust Score
Ramy czasowe: Pre-intervention baseline and monthly through intervention month 12
Participants will rate each named coalition connection using one item, "How much do you trust this person?" Responses range from 1, I do not trust this person, to 5, I trust this person. A mean trust score will first be calculated across each respondent's rated ties. Respondent-level means will then be averaged within each coalition and assessment wave. Scores range from 1 to 5. Higher scores indicate greater trust among coalition members.
Pre-intervention baseline and monthly through intervention month 12
Mean Number of Child-Health Discussion Ties per Participant
Ramy czasowe: Pre-intervention baseline and monthly through intervention month 12
At each assessment, participants may identify up to 20 people with whom they currently discuss child health promotion. The number of reported discussion ties will be calculated for each participant and averaged within each coalition. Scores range from 0 to 20 ties per participant. Higher values indicate that participants report more child-health discussion connections.
Pre-intervention baseline and monthly through intervention month 12
Mean Perceived Relative Advantage Score for the Selected Evidence-Informed Strategy
Ramy czasowe: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
relative advantage will be assessed using five adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument. Each item is scored from 1, extremely disagree, to 7, extremely agree. Item scores will be averaged. Scores range from 1 to 7. Higher scores indicate greater perceived advantage of the selected strategy compared with current approaches.
Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
Mean Perceived Compatibility Score for the Selected Evidence-Informed Strategy
Ramy czasowe: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
Perceived compatibility will be assessed using four adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument. Each item is scored from 1, extremely disagree, to 7, extremely agree. Item scores will be averaged. Scores range from 1 to 7. Higher scores indicate greater perceived compatibility with coalition needs, activities, and ways of working.
Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
Mean Perceived Ease-of-Use Score for the Selected Evidence-Informed Strategy
Ramy czasowe: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
Perceived ease of use will be assessed using three adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument. Each item is scored from 1, extremely disagree, to 7, extremely agree. Item scores will be averaged. Scores range from 1 to 7. Higher scores indicate that the selected strategy is perceived as easier to understand and use.
Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
Mean Perceived Result-Demonstrability Score for the Selected Evidence-Informed Strategy
Ramy czasowe: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
Perceived result demonstrability will be assessed using four adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument. Each item is scored from 1, extremely disagree, to 7, extremely agree. One negatively worded item will be reverse-coded, and the four item scores will be averaged. Scores range from 1 to 7. Higher scores indicate that the expected results of the selected strategy are perceived as more observable and easier to communicate.
Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
Mean Perceived Trialability Score for the Selected Evidence-Informed Strategy
Ramy czasowe: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
Perceived trialability will be assessed using two adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument. Each item is scored from 1, extremely disagree, to 7, extremely agree. Item scores will be averaged. Scores range from 1 to 7. Higher scores indicate greater perceived ability to test the selected strategy before full implementation.
Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
Mean Evidence-Input Domain Score on the Structured Interview for Evidence Use
Ramy czasowe: Intervention months 6, 9, and 12
Evidence acquisition will be assessed using the six-item Input domain of the Structured Interview for Evidence Use brief form. Items assess how often participants obtain evidence from professional networks, experts, academic journals, and training materials. Each item is scored from 1, not at all, to 5, all the time. Item scores will be averaged to produce a score ranging from 1 to 5. Higher scores indicate more frequent acquisition of evidence. Mean scores will be reported separately for each assessment time point.
Intervention months 6, 9, and 12
Mean Evidence-Appraisal Process Domain Score on the Structured Interview for Evidence Use
Ramy czasowe: Intervention months 6, 9, and 12
Evidence appraisal will be assessed using the seven-item Process domain of the Structured Interview for Evidence Use brief form. Items assess the importance participants place on factors such as study methods, use of multiple sources, strengths and limitations of the evidence, source trustworthiness, relevance, and cost. Each item is scored from 1, not important, to 5, very important. Item scores will be averaged to produce a score ranging from 1 to 5. Higher scores indicate greater importance placed on systematically evaluating evidence. Mean scores will be reported separately for each assessment time point.
Intervention months 6, 9, and 12
Mean Evidence-Application Output Domain Score on the Structured Interview for Evidence Use
Ramy czasowe: Intervention months 6, 9, and 12
Evidence application will be assessed using four Output-domain items from the Structured Interview for Evidence Use brief form. Items assess the importance of using evidence to support adoption decisions, determine fit with community needs, assess potential harms, and compare available strategies. Each item is scored from 1, not important, to 5, very important. Item scores will be averaged to produce a score ranging from 1 to 5. Higher scores indicate greater importance placed on applying evidence in coalition decisions. Mean scores will be reported separately for each assessment time point.
Intervention months 6, 9, and 12
Percentage of Structured Evidence-Review Milestones Completed
Ramy czasowe: Intervention months 6 and 12
Coalition progress will be assessed using four prespecified milestones: evidence was reviewed, candidate strategies were compared, a selection decision was made, and the selected evidence-informed strategy was documented. Each completed milestone receives one point. The number of completed milestones will be divided by four and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater progress through the structured evidence-review and selection process.
Intervention months 6 and 12

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Śledczy

  • Główny śledczy: Travis R Moore, PhD, University of Pittsburgh

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 stycznia 2027

Zakończenie podstawowe (Szacowany)

1 czerwca 2028

Ukończenie studiów (Szacowany)

1 czerwca 2029

Daty rejestracji na studia

Pierwszy przesłany

27 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

4 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

31 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • STUDY26070049
  • 4R00HD109456-03 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

De-identified individual participant data included in the final analytic datasets underlying reported results will be shared. These data may include cleaned participant-level survey responses, outcome scores, and derived participant-level variables. Associated data dictionaries, codebooks, variable-derivation documentation, and analytic code will also be provided. Direct identifiers, contact and linkage files, recordings, transcripts that cannot be safely de-identified, raw network-nomination files, and data presenting an unacceptable risk of deductive disclosure will not be shared. Detailed network data may be masked, aggregated, or made available through controlled access following disclosure-risk review.

Ramy czasowe udostępniania IPD

Data and supporting information will become available no later than the date of the first associated publication or the end of the award period, whichever occurs first. Materials will remain available for at least 10 years, subject to repository policies.

Kryteria dostępu do udostępniania IPD

Data will be deposited in ICPSR or another appropriate NIH-compliant repository. Qualified researchers may request access by submitting a research proposal describing the scientific purpose, requested data, analysis plan, data-security procedures, and plans for dissemination. Requests will be reviewed for scientific appropriateness, privacy and deductive-disclosure risk, consistency with participant consent, and compliance with applicable IRB and institutional requirements. Access may require a data use agreement, appropriate ethics approval, secure data storage, and agreement not to re-identify or contact participants, redistribute the data, or use the data beyond the approved purpose. Detailed network data may be restricted, masked, or aggregated when necessary to protect participants and participating coalitions.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .